Humacyte Ships Engineered Blood Vessels to Treat War Wounds in Ukraine
Durham-based Humacyte is providing engineered blood vessels to multiple hospitals in Ukraine for treating wounded civilians and soldiers with vascular injuries suffered in the Russian invasion.
The clinical-stage biotech company on Tuesday began the first shipment of its Human Acellular Vessels (HAVs), off-the-shelf, universal replacement vessels being developed for vascular repair, reconstruction, and replacement.
Humacyte worked with the Office of International Programs within the U.S. Food and Drug Administration (FDA) as well as the Ukraine Ministry of Health to coordinate export and import of the investigational HAVs for humanitarian use.
Six hospitals in Ukraine, including in Kyiv, Kharkiv and other cities, will receive the initial shipment, and requests from additional hospitals are being processed, the company said in a news release.
“Humacyte is proud to contribute to the ongoing Ukraine medical relief and to support the patients and the brave medical providers on the ground during this humanitarian crisis,” said Laura Niklason, M.D., Ph.D., chief executive officer of Humacyte. “I’m immensely grateful to the Humacyte team for their tireless work seeing this through, as well as clinicians in Poland and the U.S. who have volunteered to assist in training Ukrainian physicians in the use of the HAV.”
The initiative began when a Ukrainian surgeon who was familiar with the HAVs requested them.
“Quickly, requests grew from other surgeons and sites around Ukraine,” Niklason said. “We continue to receive requests from local surgeons for the product candidate and plan to coordinate shipments to additional hospital sites as soon as possible.”
Humacyte’s 83,000-square-foot commercial manufacturing facility is already operational, allowing the company to provide HAVs while also meeting the requirements of its ongoing HAV clinical trials, Niklason said.
“While outside the scope of our pivotal trauma trial, we expect this humanitarian effort will provide additional real-world evidence of the potential impact of the HAV in the treatment of vascular trauma injuries,” she said.
The HAV is an investigational product and has not been approved for sale by the FDA or any international regulatory agency. It has received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense.
The product, made in varying diameters and lengths and shipped in a flexible bag, is intended to overcome long-standing limitations in vessel tissue repair and replacement. According to Humacyte, it can be manufactured at commercial scale, it eliminates the need for harvesting a vessel from a patient, and clinical evidence suggests that it is non-immunogenic, infection-resistant, and can become durable living tissue.
The HAV is being evaluated in a Phase 2/3 clinical trial in vascular trauma for use as a vascular replacement to restore blood flow to a limb, when saphenous veins or synthetic grafts are not a good option. It is also being evaluated in two Phase 3 trials in arteriovenous access for performing hemodialysis.
The product has been used in more than 460 patient implantations.
Humacyte’s 6mm HAV for arteriovenous access for performing hemodialysis was the first product to receive Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and has also received FDA Fast Track designation.
Humacyte is also doing preclinical work to develop potential applications in coronary artery bypass grafts, pediatric heart surgery, type 1 diabetes, and multiple novel cell and tissue applications.
Humacyte was founded in 2004, and the North Carolina Biotechnology Center provided it a $150,000 Small Business Research Loan in 2006.
Since then, Humacyte raised nearly $480 million, including a $150 million equity investment from Fresenius Medical Care, the world's leading provider of products and services for patients with renal diseases and for surgical care centers.
Humacyte became a publicly traded company in August 2021 through a SPAC deal, a merger with a special purpose acquisition company. Its shares are traded on the Nasdaq stock exchange under the symbol HUMA.